ConstipationNOPALNCT03263065
A Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging
A study testing Bran, Nopal and Psyllium in people with Constipation and Diet Modification, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study will compare 3 food products (bran, psyllium and nopal) on intestinal water content measured via MRI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation, Diet Modification
- What is being tested?
- Bran, Nopal and Psyllium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Able to give informed consent
Who cannot join
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
- Intestinal stoma
- Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products
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- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Will not agree to dietary restrictions required in 24 hours before each MRI study day
- Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- Inability to lie flat or exceed scanner limits of weight <120kg
- Poor understanding of English language
- Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM
- Participation in any medical trials for the past 3 months
- Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: A Pilot Participant-blind Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging
This study will compare 3 food products (bran, psyllium and nopal) on intestinal water content measured via MRI.
Read the detailed description
BACKGROUND AND RATIONALE
The role of dietary fibre in human health is a topic of both debate and research. Interpreting evidence is complicated by changes in the definition of fibre. In the UK the Scientific Advisory Committee for Nutrition has recently proposed a definition of "all carbohydrates that are neither digested nor absorbed in the small intestine and have a degree of polymerisation of three or more monomeric units, plus lignin". They have also called for further research into the physiological effects of fibre of the gastrointestinal (GI) tract.
The Nottingham GI MRI group has been at the forefront of elucidating the effects of poorly digested carbohydrates on gastrointestinal physiology. The investigators have published techniques to measure free water in the small bowel and assessment of the physical form of chyme in the colon using MR relaxometry. This includes the demonstration that fructose ingestion on its own leads to increased free water in the small bowel compared to co-ingestion with glucose.
Bran is often confused with dietary fibre. Although it contains fibre, the term actually refers to the outer husk of seeds and grains. It has been shown to accelerate oro-caecal transit (OCT) with scintigraphy. Bran can also be shown to increase small bowel water content, possibly by mechanical stimulation, one of the most powerful stimuli for small intestinal secretion, which may be a mechanism to prevent blockage. In the past bran's high fibre content led to the hypothesis that its effect derived from holding water in the lumen but a comparison study of 17 different fibres found an inverse relationship between their water-holding properties and effect on faecal weight, with bran holding the least water but inducing the largest weight changes. Rather, weight change appeared to relate to the amount of undigested fibre present in the faeces and the associated changes in bacterial numbers, which account for most of dry stool weight.
In contrast, psyllium husk contains a fibre that binds water effectively. On this basis it has been used as a laxative for thousands of years. In fact, there is little evidence that psyllium accelerates whole gut transit time as might be expected of a laxative. Work within the investigating group has shown that psyllium increases water in both the small bowel and the faeces, leading to softer, looser stool.
Nopal is a Mexican dietary product derived from cactus. It contains a different mix of fibre, 2/3rds of which is insoluble like bran fibre and 1/3rd soluble like psyllium. It is the subject of several health claims. The investigating group has recently been awarded a grant by the Newton Fund, through the Medical Research council, to study its effects on gut function. The aim of the Newton Fund is to stimulate collaborative research with middle-income countries such as Mexico. Part of the project plan is to invite a Mexican radiologist, Dr Alfonso Gil-Valadez, to Nottingham to learn about the MRI techniques used by our group.
TRIAL OBJECTIVES AND PURPOSE
Purpose
The purpose of the study is to gather pilot data on the effect of Nopal on intestinal water content, in comparison to bran and psyllium.
Objective
The primary objective is to gather pilot data on the change from baseline in small bowel water content in healthy volunteers after a meal containing nopal, in comparison to meals containing psyllium or bran.
Secondary Objectives
Secondary objectives will be to gather pilot data on the effects of the fibre-containing meals on the physical form of colonic chyme, colonic volume and breath markers of fermentation.
Hypotheses
The test meals will lead to differences in post-prandial water in the small bowel.
The test meals will lead to differences in the post-prandial volume and physical composition of chyme in the colon.
The test meals will not lead to change in breath markers of fermentation.
- Conditions
- Constipation, Diet Modification
- Being tested
- Bran, Nopal, Psyllium
- Keywords
- Nopal, Bran, Psyllium
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BranDietary supplement
220g rice pudding meal with raspberry jam with added bran flakes
NopalDietary supplement
220g rice pudding meal with raspberry jam with added nopal flakes
PsylliumDietary supplement
220g rice pudding meal with raspberry jam with added psyllium flakes
| Study group | Role | What they receive |
|---|---|---|
| Nopal added to test meal | Experimental | test meal including nopal powder Receives: Dietary Supplement: Nopal |
| Psyllium added to test meal | Experimental | test meal including psyllium powder Receives: Dietary Supplement: Psyllium |
| Bran added to test meal | Experimental | test meal including bran powder Receives: Dietary Supplement: Bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon
measured by MRI
Measured: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Secondary outcomes (3)
Change from the baseline in small bowel water content (mL)
measured by MRI
Measured: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Change from the baseline in colonic volume in mL
measured by MRI
Measured: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Change from the baseline of breath hydrogen and methane (ppm)
measured using GastroCHeck
Measured: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start18 Apr 2018
- Primary completion1 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a three-period, three-treatment crossover trial with blinding of data analysis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, PhD, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263065
- Sponsor's protocol ID
- NOPAL
- Acronym
- NOPAL
- Status last verified
- May 2018
- First submitted
- 21 Aug 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunn D, Murthy R, Major G, Wilkinson-Smith V, Hoad C, Marciani L, Remes-Troche J, Gill S, Rossi M, Harris H, Ahn-Jarvis J, Warren F, Whelan K, Spiller R. Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial. Am J Clin Nutr. 2020 Sep 1;112(3):595-602. doi: 10.1093/ajcn/nqaa173.
PubMed 32619212
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Participant-blind Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03263065
- Acronym / sponsor ID
- NOPAL / NOPAL
- Conditions
- Constipation, Diet Modification
- Keywords
- Nopal, Bran, Psyllium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare 3 food products (bran, psyllium and nopal) on intestinal water content measured via MRI.
Detailed description
BACKGROUND AND RATIONALE
The role of dietary fibre in human health is a topic of both debate and research. Interpreting evidence is complicated by changes in the definition of fibre. In the UK the Scientific Advisory Committee for Nutrition has recently proposed a definition of "all carbohydrates that are neither digested nor absorbed in the small intestine and have a degree of polymerisation of three or more monomeric units, plus lignin". They have also called for further research into the physiological effects of fibre of the gastrointestinal (GI) tract.
The Nottingham GI MRI group has been at the forefront of elucidating the effects of poorly digested carbohydrates on gastrointestinal physiology. The investigators have published techniques to measure free water in the small bowel and assessment of the physical form of chyme in the colon using MR relaxometry. This includes the demonstration that fructose ingestion on its own leads to increased free water in the small bowel compared to co-ingestion with glucose.
Bran is often confused with dietary fibre. Although it contains fibre, the term actually refers to the outer husk of seeds and grains. It has been shown to accelerate oro-caecal transit (OCT) with scintigraphy. Bran can also be shown to increase small bowel water content, possibly by mechanical stimulation, one of the most powerful stimuli for small intestinal secretion, which may be a mechanism to prevent blockage. In the past bran's high fibre content led to the hypothesis that its effect derived from holding water in the lumen but a comparison study of 17 different fibres found an inverse relationship between their water-holding properties and effect on faecal weight, with bran holding the least water but inducing the largest weight changes. Rather, weight change appeared to relate to the amount of undigested fibre present in the faeces and the associated changes in bacterial numbers, which account for most of dry stool weight.
In contrast, psyllium husk contains a fibre that binds water effectively. On this basis it has been used as a laxative for thousands of years. In fact, there is little evidence that psyllium accelerates whole gut transit time as might be expected of a laxative. Work within the investigating group has shown that psyllium increases water in both the small bowel and the faeces, leading to softer, looser stool.
Nopal is a Mexican dietary product derived from cactus. It contains a different mix of fibre, 2/3rds of which is insoluble like bran fibre and 1/3rd soluble like psyllium. It is the subject of several health claims. The investigating group has recently been awarded a grant by the Newton Fund, through the Medical Research council, to study its effects on gut function. The aim of the Newton Fund is to stimulate collaborative research with middle-income countries such as Mexico. Part of the project plan is to invite a Mexican radiologist, Dr Alfonso Gil-Valadez, to Nottingham to learn about the MRI techniques used by our group.
TRIAL OBJECTIVES AND PURPOSE
Purpose
The purpose of the study is to gather pilot data on the effect of Nopal on intestinal water content, in comparison to bran and psyllium.
Objective
The primary objective is to gather pilot data on the change from baseline in small bowel water content in healthy volunteers after a meal containing nopal, in comparison to meals containing psyllium or bran.
Secondary Objectives
Secondary objectives will be to gather pilot data on the effects of the fibre-containing meals on the physical form of colonic chyme, colonic volume and breath markers of fermentation.
Hypotheses
The test meals will lead to differences in post-prandial water in the small bowel.
The test meals will lead to differences in the post-prandial volume and physical composition of chyme in the colon.
The test meals will not lead to change in breath markers of fermentation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This will be a three-period, three-treatment crossover trial with blinding of data analysis
| Arm | Type | Receives |
|---|---|---|
| Nopal added to test meal | Experimental | Dietary Supplement: Nopaltest meal including nopal powder |
| Psyllium added to test meal | Experimental | Dietary Supplement: Psylliumtest meal including psyllium powder |
| Bran added to test meal | Experimental | Dietary Supplement: Brantest meal including bran powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 or older
- Able to give informed consent
Key exclusion criteria (14 listed)
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
- Intestinal stoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bran220g rice pudding meal with raspberry jam with added bran flakes | Dietary supplement | Bran added to test meal |
| Nopal220g rice pudding meal with raspberry jam with added nopal flakes | Dietary supplement | Nopal added to test meal |
| Psyllium220g rice pudding meal with raspberry jam with added psyllium flakes | Dietary supplement | Psyllium added to test meal |
Primary outcome
Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon
Time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
measured by MRI
3 secondary outcomes
Change from the baseline in small bowel water content (mL)
Time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Change from the baseline in colonic volume in mL
Time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Change from the baseline of breath hydrogen and methane (ppm)
Time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 32619212Gunn D, Murthy R, Major G, Wilkinson-Smith V, Hoad C, Marciani L, Remes-Troche J, Gill S, Rossi M, Harris H, Ahn-Jarvis J, Warren F, Whelan K, Spiller R. Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial. Am J Clin Nutr. 2020 Sep 1;112(3):595-602. doi: 10.1093/ajcn/nqaa173.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Spiller, PhD study chair
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bran, Nopal and Psyllium in people with Constipation and Diet Modification, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon (time frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03263065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.